Kornimate/medical-research-clean huggingface dataset:
unboosted atazanavir as initial art therapy in china

Conditions: Antiretroviral Therapy

Summary: this is an open-label, pilot study.the study hypothesis is that the feasibility and efficacy of a non-boosted atv based haart will be well as the first line treatment in a chinese resource-limited setting.


Eligibility criteria:
inclusion criteria: * signed written informed consent * the subject should have established hiv infection more than 6 month. * qualifying plasma hiv rna ≥ 2,000 c/ml and a cd4 cell count within 100 - 350 cells/mm3 * ≥16 years of age * both females of child-bearing potential and males must utilize effective barrier contraception - other contraception in addition to barrier methods are permitted * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. exclusion criteria: * patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. * presence of a newly diagnosed hiv-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. * history of hemophilia * proven or suspected acute hepatitis in the 30 days prior to study entry. subjects with chronic hepatitis are eligible provided that their liver function enzymes are \< 3 times the upper limit of normal. * presence of cardiomyopathy. * a history of arrhythmia or clinical symptoms potentially related to heart block or second / third degree heart block. * inability to tolerate oral medication * presence of a newly diagnosed hiv-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.

Keywords: acquired immunodeficiency syndrome antiretroviral therapy china
a trial of hr021618 in postsurgical pain management

Conditions: Postsurgical Pain Management

Summary: the study is being conducted to evaluate the efficacy, safety of hr021618 and to explore the reasonable dosage of hr021618 for pain management after orthopaedic surgery.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects requiring elective orthopaedic surgery 3. male or female 4. meet the weight standard 5. conform to the asa physical status classification postoperative randomization criteria exclusion criteria 1、 sufficient pain to require ivanalgesia assessed by nrs ranging 2、 no evidence of organ insufficiency, or any other abnormality, during or following surgery exclusion criteria: 1. history of major surgery 2. history of active or high-risk bleeding disorders 3. history of myocardial infarction or coronary artery bypass 4. history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study 5. abnormal values in the laboratory 6. have a known allergy to meloxicam or any excipient of hr021618, , aspirin, other non-steroidal anti-inflammatory drugs (nsaids) or to any peri- or postoperative medications used in this study 7. use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives 8. planned/actual admission to the intensive care unit 9. pregnant or nursing women 10. no birth control during the specified period of time 11. participated in clinical trials of other drugs (received experimental drugs) 12. the inestigators determined that other conditions were inappropriate for participation in this clinical trial
predictors of post-alteplase hemorrhagic transformation of brain infarction

Conditions: Ischemic Stroke; Alteplase Adverse Reaction

Summary: the investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

investigators conducted a prospective cohort study between june 2021 and october 2023. they screened 1450 patients who presented with ais and received alteplase and included 616 ais patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination, and specific brain imaging results and treated with alteplase within four and half hours of stroke onset. the investigators assessed the patients' follow-up brain imaging to detect the subtypes of hemorrhagic transformation after receiving alteplase. the study consisted of two distinct groups. the first group consisted of 464 patients who did not experience hemorrhagic infarction, while the second group comprised 152 patients who experienced hemorrhagic infarction. the investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

Eligibility criteria:
inclusion criteria: * the investigators enrolled individuals of both genders, aged between 18 and 75, who presented with acute first-ever ischemic stroke and were eligible for thrombolysis. exclusion criteria: * the investigators excluded patients who had not been followed up on for 90 days after enrollment, those with alteplase contraindications or did not receive the total dose of alteplase due to any reason were excluded the investigators excluded patients with a known history of persistent or recurrent cns pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit). the investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or mri brain findings. the investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks. the investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest

Keywords: alteplase hemorragic infarction egypt saudi arabia acute ischemic stroke
effectiveness of ottobock helmet therapy in infants with plagiocephaly, brachycephaly or combination of both

Conditions: Plagiocephaly, Positional; Plagiocephaly, Nonsynostotic; Brachycephaly

Summary: the objective of the research is to measure the effectiveness of the ottobock helmet, an innovative 3d-printed cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both. this research is a retrospective multi-centric study composed of a collection of clinical data from orthotists database and a survey for patient's parents.

the ottobock helmet is a cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both. this medical device is a 3d-printed helmet, with an elastic closing system which allow the head growth, maintain a constant pressure in the helmet and ensure a good adjustment. even though there is an effectiveness observed, there are no existing clinical evidences on this type of helmet so far, and there is a need to conduct a research on a large number of patients to measure the effectiveness and describe the population treated. this study will give more information to health professionals (doctors, orthopedic technicians, etc.) and health authorities, about the benefits of the orthopedic treatment of the positional cranial deformations in infants. the study is composed of an electronic case report form (ecrf) to be fulfilled by the orthotists and an electronic questionnaire (epro) to be fulfilled by the patient's parents. the electronic questionnaires, data treatment and analysis are handled by a contract research organization (cro).

Eligibility criteria:
inclusion criteria: * infant with positional cranial deformation * infant treated with an ottobock helmet between may 1st, 2020 and may 1st, 2021 exclusion criteria: * patient whose parents (or legal guardians) disagree to participate in the study. * patient whose parents (or legal guardians) are unable to understand or answer the questionnaire.

Keywords: cranial orthosis helmet treatment
bioequivalence study of lamotrigine 25 mg chewable tablets of dr.reddy's under fed condition

Conditions: Healthy

Summary: the purpose of this study is to determine the pharmacokinetics and bioequivalence of lamotrigine formulations after administration of single doses to non-smoking, healthy males and females under fed conditions

a single-dose, two-way, bioequivalence study in up to 24 normal, non-smoking, healthy males and females will be utilized to evaluate the pharmacokinetics and bioequivalence of lamotrigine chewable dispersible formulations under fed conditions.

Eligibility criteria:
inclusion criteria: * healthy males and females at least 18 years of age inclusive. * informed of the nature of the study and given written informed consent. * have a body weight within 15% of the appropriate range as defined in the * 1983 metropolitan life company tables and weighing at least 100 lbs. (appendix i and ii). exclusion criteria: * hypersensitivity to lamotrigine' (lamictal®), or similar compounds. * any history of a clinical condition which might affect drug absorption, metabolism or excretion. * recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism. * donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood. * received an investigational drug within the 4 weeks prior to study dosing. * currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing; this prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician. * tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing. * if female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, iud, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

Keywords: bioequivalence crossover lamotrigine (chewable, dispersible)
intramuscular and intravenous vir-7831 (sotrovimab) for mild/moderate covid-19.

Conditions: Covid19

Summary: the comet-tail main study evaluated efficacy, safety, and tolerability of im sotrovimab versus iv sotrovimab in high-risk patients for the treatment of mild/moderate covid-19. in the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate covid-19 to participants at high risk of disease progression main study was completed successfully. the safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (ic50) and uncertainty in the clinical relevance of these changes.


Eligibility criteria:
inclusion criteria: * main study participant must be aged 12 years or older and at high risk of progression of covid-19 or \> 55 years old * sub-study participants must be aged 18 years or older at time of consent and at high risk of progression of covid-19 or ≥ 55 years old * participants must have a positive sars-cov-2 test result and oxygen saturation ≥94% on room air and have covid-19 symptoms and be less than or equal to 7 days from onset of symptoms exclusion criteria: * currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours * symptoms consistent with severe covid-19 * participants who, in the judgement of the investigator are likely to die in the next 7 days * known hypersensitivity to any constituent present in the investigational product

Keywords: sars-cov-2 coronavirus disease 2019 covid-19 early treatment coronavirus
social distancing during the covid-19 pandemic and people living with chronic respiratory diseases

Conditions: Chronic Obstructive Pulmonary Disease; Idiopathic Pulmonary Fibrosis; Asthma Chronic

Summary: social distancing during the covid-19 pandemic could lead to clinical and functional deterioration of people living with chronic respiratory diseases (crd). as they are considered risk group for covid-19, it is not recommended that they leave their house and have interaction with people outside. thus, most of them have not been attend pulmonary rehabilitation sections since the beginning of pandemic, neither exercising outdoor, experiencing drastic restrictions in their activities of daily living. it is well known that low level of physical activity in daily life (padl) in this population is related to poor prognosis, including higher chance of hospitalization due to exacerbation and mortality. therefore, the aim of this study is to evaluate the short- and mid-term impact of the covid-19 pandemic on the clinical, physical and functional conditions and the padl level of people living with crd (chronic obstructive pulmonary disease, asthma and interstitial lung diseases). participants will be assessed during the social isolation period and they will be reassessed immediately after release from social isolation. thus, the subjects will be followed-up during 12 months to record symptoms, functional status, quality of life, exacerbations and hospitalizations. the researchers' hypothesis is that those patients will present very low level of padl in association to sedentarism, poor functional status, more symptoms of dyspnoea, anxiety and depression, poor sleep quality and, consequently, will present more episodes of acute exacerbation of the disease and more hospital admission during the study protocol.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease, asthma or interstitial lung disease; * absence of any severe and/or unstable cardiac disease; * absence of any orthopedic or neuromuscular condition that limits physical activity in daily life. exclusion criteria: * desire to leave the study at any time; * infection with sars-cov-2 during the study protocol.

Keywords: physical inactivity sedentarism chronic lung diseases
oxytocin, couple interaction and wound healing

Conditions: Healthy Volunteers

Summary: effects of intranasal oxytocin and couple interaction on wound healing. * trial with medicinal product


Eligibility criteria:
inclusion criteria: * healthy heterosexual couples * in a stable relationship since \> 1 year exclusion criteria: pregnancy * breast feeding * heavy smoking (\> 5 cigarettes/d) * extensive skin disease * artificial uv irradiation during \< 3 months before study inclusion
hepatitis b vaccine in patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: the objective is to assess the efficacy of hepatitis b virus vaccination in a population of ibd patients treated with immunosuppressive medications.


Eligibility criteria:
inclusion criteria: * male/female ≥ 18 years of age * evidence of ibd as diagnosed by clinical, laboratory imaging and endoscopic criteria. * treated with at least one immunosuppressive medication at the time of study initiation * provided written informed consent. exclusion criteria: * pregnant women * diagnosis of chronic viral hepatitis b * any major acute medical event in the 30 days prior to recruitment that necessitated hospitalization ( acute myocardial infarction, cva, pulmonary emboli, sepsis, major trauma) * any other chronic inflammatory condition not related to ibd ( connective tissue disease, chronic liver disease, copd, poorly controlled diabetes mellitus) * active hematologic or oncologic diseases

Keywords: hbv, inflammatory bowel disease, immunosuppressor
a non-randomized, open-label study to evaluate the safety and effectiveness of the dayspring technology for patients with breast cancer related lymphedema (bcrl) after lymphatic surgery

Conditions: Lymphedema; Lymphedema, Breast Cancer; Lymphedema Arm

Summary: to evaluate the dayspring active wearable compression technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

to evaluate the dayspring active wearable compression technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age * willing to sign the informed consent and deemed capable of following the study protocol * subjects must have a diagnosis of upper extremity edema and have or will undergo lymphatic surgery with dr. nguyen * subjects must have a difference in volume greater than 3% between the limbs. exclusion criteria: * individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy * inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent * patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) * diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer * patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device * diagnosis of lipedema * diagnosis of acute infection. the source of the infection must be treated for 2 weeks prior to admittance into the study * diagnosis of acute thrombophlebitis (in last 2 months) * diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months * diagnosis of pulmonary edema * diagnosis of congestive heart failure (uncontrolled) * diagnosis of chronic kidney disease * diagnosis of epilepsy * patients with poorly controlled asthma * women who are pregnant, planning a pregnancy or nursing at study entry * participation in any clinical trial of an investigational substance or device during the past 30 days * bilateral limb edema
effects of caffeine on methacholine challenge and exhaled nitric oxide levels.

Conditions: Asthma

Summary: to investigate whether or not the ingestion of caffeine with alter airway responsiveness to methacholine and/or change the level of exhaled nitric oxide.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma * fev1 greater than 65% exclusion criteria: * asthma is poorly controlled * presence of other airway disease (e.g. copd)
exploring the changes of inflammatory factors in joint fluid of patients with sports injury for 1-year postoperative rehabilitation and clinical treatment

Conditions: Anterior Cruciate Ligament Injuries

Summary: this study intends to use a prospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department from january 2020 to january 2022. the aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery.

this study intends to use a retrospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department starting from january 2021. the aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery. the indicators of postoperative rehabilitation for patients were objectively evaluated using three scales: lysholm scale, vas scale, and tegner scale. among them, the lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. the higher the value, the better the recovery; the vas scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. the higher the value, the more severe the pain; the tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. the higher the value, the better the recovery.

Eligibility criteria:
inclusion criteria: * those with healthy diet and regular exercise habits; * sports injury patients(satisfy one of the following conditions): anterior cruciate ligament injury or meniscus injury exclusion criteria: * existence of underlying diseases related to the immune system; * trauma leading to knee joint fracture; * blood pressure, heart rate, vital capacity, muscle tension and other indicators are obviously abnormal; * significant abnormalities in blood routine, infection indicators, heart, lung, liver, and kidney function tests, insufficient compensatory function of important organs, or severe systemic diseases; * patients with neurological or psychiatric disorders, pregnant women, or a history of related illnesses combined with severe organic diseases
chronic venous disorders management and treatment effectiveness evaluation in chronic venous disease, an international program

Conditions: Chronic Venous Disease

Summary: the primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for cvd


Eligibility criteria:
inclusion criteria: * age ≥18 years old * patient consulting spontaneously or referred for symptomatic venous disorders * diagnosis of chronic venous disease according to investigator's judgment exclusion criteria: * presence of known severe systemic disease likely to interfere with the study evaluation * patients with lower limb arterial disease * patient with any other concomitant disease or treatment that may interfere with lower limb pain or edema * patient consulting for an emergency not related to venous disease * patient currently taking any treatment for chronic venous disorders, either with venoactive drug or with compression hosiery * procedure or surgery for venous disease planned during the study * pregnant or breastfeeding woman

Keywords: observationnal qol